NCT07044986

Brief Summary

This study will include 30 individuals diagnosed with Generalized Joint Hypermobility (GJH) based on the Beighton score and 30 healthy controls without GJH. Participants will undergo Tinel's test and the flexion-compression test. The presence of ulnar nerve-related symptoms such as pain and numbness will be recorded. Ultrasonographic evaluation of the ulnar nerve will be performed at the level of the medial epicondyle, as well as 2 cm proximal and distal to it. Cross-sectional area and diameter of the ulnar nerve will be measured at each site, repeated three times, and the average will be used. Additionally, ulnar nerve mobility during elbow flexion and extension will be assessed. The nerve will be classified as stable if it remains within the cubital tunnel, subluxated if it moves to the level of the epicondyle, and dislocated if it shifts anterior to the medial epicondyle.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
60

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Jul 2025

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 22, 2025

Completed
9 days until next milestone

First Posted

Study publicly available on registry

July 1, 2025

Completed
Same day until next milestone

Study Start

First participant enrolled

July 1, 2025

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2025

Completed
Last Updated

July 1, 2025

Status Verified

June 1, 2025

Enrollment Period

1 month

First QC Date

June 22, 2025

Last Update Submit

June 22, 2025

Conditions

Outcome Measures

Primary Outcomes (5)

  • Ulnar nerve cross-sectional area (CSA) at the medial epicondyle

    CSA measurement provides insight into nerve thickening, which may indicate entrapment or irritation.

    0 day

  • Ulnar nerve cross-sectional area (CSA) at the 2 cm proximal of medial epicondyle

    CSA measurement provides insight into nerve thickening, which may indicate entrapment or irritation.

    0 day

  • Ulnar nerve cross-sectional area (CSA) at the 2 cm distal of medial epicondyle

    CSA measurement provides insight into nerve thickening, which may indicate entrapment or irritation.

    0 day

  • Ulnar nerve diameter

    Ulnar nerve diameter with ultrasonography

    0 day

  • Ulnar nerve mobility classification during elbow flexion (stable/subluxated/dislocated)

    Dynamic USG evaluation allows visualization of nerve movement and instability during joint motion.

    0 day

Secondary Outcomes (1)

  • Presence of ulnar nerve-related symptoms:

    0 day

Study Arms (2)

hypermobility

patients with generalized joint hypermobility snyndrome

Other: no intervention

Control group

healthy control

Other: no intervention

Interventions

no intervention

Control grouphypermobility

Eligibility Criteria

Age18 Years - 40 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)
Sampling MethodProbability Sample
Study Population

hypermobility and healthy controls

You may qualify if:

  • Aged between 18 and 40 years
  • A Beighton score of 4 or higher (indicative of Generalized Joint Hypermobility)
  • Willingness to participate in the study

You may not qualify if:

  • Being under 18 or over 40 years of age
  • History of surgery or fracture in the elbow region
  • Presence of active infection at the measurement site
  • Presence of congenital anomaly in the upper extremity
  • History of surgery involving neural structures in the upper extremity
  • Presence of malignancy
  • Pregnancy
  • Presence of cognitive or psychiatric disorders

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Beylikdüzü State Hospital

Istanbul, Beylikdüzü, 34147, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Joint Instability

Condition Hierarchy (Ancestors)

Joint DiseasesMusculoskeletal Diseases

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
CROSS SECTIONAL
Target Duration
1 Day
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principle Investigator

Study Record Dates

First Submitted

June 22, 2025

First Posted

July 1, 2025

Study Start

July 1, 2025

Primary Completion

August 1, 2025

Study Completion

August 1, 2025

Last Updated

July 1, 2025

Record last verified: 2025-06

Locations